<p>This International Standard specifies requirements and guidance for processing practices and managing risk</p>
<p>associated with viable cellular components of products regulated as medicinal products, biologics, medical</p>
<p>devices and active implantable medical devices, or combinations thereof. It covers viable human materials of</p>
<p>autologous as well as allogeneic human origin, obtained from living or deceased donors.</p>
<p>For manufacturers of medical products containing viable cells of human origin, this International Standard</p>
<p>specifies procedures to be used in processing and handling, as well as those to be used in identifying the</p>
<p>hazards and hazardous situations associated with such cells, in order to estimate and evaluate the resulting</p>
<p>risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, this International</p>
<p>Standard outlines the decision process for the residual risk acceptability, taking into account the balance of</p>
<p>residual risk and expected medical benefit as compared to available alternatives.</p>
<p>This International Standard provides requirements and guidance on risk management related to the hazards</p>
<p>typical of medical products manufactured utilizing viable human materials, such as:</p>
<p>a) contamination by bacteria, moulds, yeasts or parasites;</p>
<p>b) contamination by viruses;</p>
<p>c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);</p>
<p>d) contaminating material responsible for undesired pyrogenic, immunological or toxicological reactions;</p>
<p>e) decomposition of the product and degradation products caused by inadequate handling;</p>
<p>f) hazards related to the tumorigenic potential of the cell types used;</p>
<p>g) complications resulting from unintended physiological and anatomical consequences (this includes</p>
<p>unintended migration of cells, unwanted release of biologically active substances such as hormones and</p>
<p>cytokines, and unintended interactions between cellular and non‑cellular components of the product);</p>
<p>h) failure of traceability;</p>
<p>i) complications resulting from the material eliciting an unintended immunogenic reaction.</p>
<p>For the evaluation of contamination with other unclassified pathogenic entities, similar principles might be applicable.</p>
<p>Hazards related to genetic modification are outside the scope of this International Standard and are</p>
<p>addressed elsewhere.</p>
<p>NOTE 1 A definition of "genetically modified" can be found in ASTM F2312.</p>
<p>NOTE 2 This International Standard does not specify a quality management system for the control of all stages of</p>
<p>production of medical products as described above.</p>
<p>If additional national or regional criteria beyond what is defined in this International Standard exist in the</p>
<p>country where the medical product will be used, they are also applicable.</p>
<p>NOTE 3 Regional requirements can be more stringent than requirements referenced in this International Standard,</p>
<p>especially with regard to donor eligibility criteria.</p>
<p>This International Standard is not applicable to:</p>
<p>— non‑viable materials of human origin;</p>
<p>— viable cells of non‑human origin;</p>
<p>— blood and its components used for transfusion, germ cells, organs and bone marrow used for transplantation,</p>
<p>and other tissues that do not meet the definition of "medical product";</p>
<p>— <i>in vitro </i>diagnostic devices.</p>
<p>NOTE 4 For guidance on the application of this International Standard, see Annex A.</p>
Registration number (WIID)
52368
Scope
<p>This International Standard specifies requirements and guidance for processing practices and managing risk</p>
<p>associated with viable cellular components of products regulated as medicinal products, biologics, medical</p>
<p>devices and active implantable medical devices, or combinations thereof. It covers viable human materials of</p>
<p>autologous as well as allogeneic human origin, obtained from living or deceased donors.</p>
<p>For manufacturers of medical products containing viable cells of human origin, this International Standard</p>
<p>specifies procedures to be used in processing and handling, as well as those to be used in identifying the</p>
<p>hazards and hazardous situations associated with such cells, in order to estimate and evaluate the resulting</p>
<p>risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, this International</p>
<p>Standard outlines the decision process for the residual risk acceptability, taking into account the balance of</p>
<p>residual risk and expected medical benefit as compared to available alternatives.</p>
<p>This International Standard provides requirements and guidance on risk management related to the hazards</p>
<p>typical of medical products manufactured utilizing viable human materials, such as:</p>
<p>a) contamination by bacteria, moulds, yeasts or parasites;</p>
<p>b) contamination by viruses;</p>
<p>c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);</p>
<p>d) contaminating material responsible for undesired pyrogenic, immunological or toxicological reactions;</p>
<p>e) decomposition of the product and degradation products caused by inadequate handling;</p>
<p>f) hazards related to the tumorigenic potential of the cell types used;</p>
<p>g) complications resulting from unintended physiological and anatomical consequences (this includes</p>
<p>unintended migration of cells, unwanted release of biologically active substances such as hormones and</p>
<p>cytokines, and unintended interactions between cellular and non‑cellular components of the product);</p>
<p>h) failure of traceability;</p>
<p>i) complications resulting from the material eliciting an unintended immunogenic reaction.</p>
<p>For the evaluation of contamination with other unclassified pathogenic entities, similar principles might be applicable.</p>
<p>Hazards related to genetic modification are outside the scope of this International Standard and are</p>
<p>addressed elsewhere.</p>
<p>NOTE 1 A definition of "genetically modified" can be found in ASTM F2312.</p>
<p>NOTE 2 This International Standard does not specify a quality management system for the control of all stages of</p>
<p>production of medical products as described above.</p>
<p>If additional national or regional criteria beyond what is defined in this International Standard exist in the</p>
<p>country where the medical product will be used, they are also applicable.</p>
<p>NOTE 3 Regional requirements can be more stringent than requirements referenced in this International Standard,</p>
<p>especially with regard to donor eligibility criteria.</p>
<p>This International Standard is not applicable to:</p>
<p>— non‑viable materials of human origin;</p>
<p>— viable cells of non‑human origin;</p>
<p>— blood and its components used for transfusion, germ cells, organs and bone marrow used for transplantation,</p>
<p>and other tissues that do not meet the definition of "medical product";</p>
<p>— <i>in vitro </i>diagnostic devices.</p>
<p>NOTE 4 For guidance on the application of this International Standard, see Annex A.</p>
